Now play­ing catch-up to blue­bird, Ver­tex and CRISPR send in their pitch for blood dis­or­der cell ther­a­py

If all things go ac­cord­ing to plan, the FDA could start re­view­ing the first-ever fil­ing for a CRISPR ther­a­py this No­vem­ber.

Ver­tex and CRISPR Ther­a­peu­tics say they have wrapped up their lengthy talks with the agency and got­ten reg­u­la­tors on board for a rolling re­view be­gin­ning lat­er this year — with the sub­mis­sion pack­age due to be com­plete in the first quar­ter of 2023.

While the part­ners once hoped that they would be the first to bring a once-and-done ther­a­py to the US mar­ket for sick­le cell dis­ease (SCD) and trans­fu­sion-de­pen­dent be­ta tha­lassemia (TDT), blue­bird bio beat them to the punch with the re­cent FDA ap­proval of Zyn­te­glo. The fil­ing al­so marks a slight de­lay to ear­li­er plans of fil­ing in late 2022, al­though it wasn’t en­tire­ly un­ex­pect­ed.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER